Overview

The Advanced Regenerative Manufacturing Institute (ARMl)IBioFabUSA is a Member-based non-profit, member-driven, public-private partnership with a mission to advance the bioeconomy and transform the future of human health. ARMI provides technical and wrap-around commercialization services to companies seeking to advance technologies that will contribute to this impact.

The Impact That You Will Make

ARMI is seeking an innovative, motivated scientist to join our phase-appropriate cell therapy manufacturing team. The successful candidate will use their experience and expertise to perform daily manufacturing and process development activities ensuring the generation of high-quality, cell-based therapy products for use in both research and Phase 1 clinical trials. This individual will work within a team of scientists and technicians working to scale-up processes and bring early phase manufacturing processes into phase-appropriate compliance with Good Manufacturing Practices (GMP). This role requires particularly strong attention to detail, experience with phase-appropriate GMP manufacturing, and the ability to think outside the box to propose creative solutions. The ideal candidate will have experience with process development or early phase GMP manufacturing, aseptic techniques and operations within a controlled manufacturing environment, SOP/Batch Record drafting, and other aspects of contract manufacturing.

Your Role

Leadership and Oversight

• Provide guidance to technicians.
• Collaborate with cross-functional teams including Quality, Facilities, and Project Management.
• Engage on multiple projects simultaneously and confidentially while working with the team to meet critical timelines and deliverables.
• Work with management to ensure robust work schedules.

Process Execution & Documentation

• Comply with GMP and safety standards.
• Perform technology transfers into and within ARMI's facility.
• Draft accurate SOPs, technical documentation, and batch records as needed.
• Report production deviations and manufacturing issues, performing root cause analysis, and aiding in the implementation of corrective actions.

Instrumentation & Maintenance

• Collaborate with Operations, service engineers, and vendors for process equipment, calibration, preventative maintenance, optimization, and upgrades.
• Maintain proper training on process and safety procedures.

Your Skills and Experiences

Education & Experience

• Biotechnology, Biology, Biochemistry, or related life science degree. BS/MS with 2-4 years of experience in cell therapy manufacturing in an MSAT or GMP production role.
• Demonstrated experience working within cross-functional teams.

Technical Skills

• Experience with clean room operations for cell therapy production.
• Familiarity with process equipment including a variety of cell culture technologies from flasks to stirred tank reactors, counterflow and continuous centrifugation, etc.
• Demonstrated knowledge of GMP regulations.

Personal Attributes

• Commitment to quality, scientific integrity, and company mission
• Strong analytical and proactive problem-solving skills with a strong attention to detail
• Excellent written and verbal communication abilities
• Ability to work independently and manage competing priorities
• Team-oriented mindset with collaborative cross-functional approach

Working Conditions

• Cleanroom laboratory environment with exposure to biologics, chemical reagents, and analytical instruments
• Shift: Sunday - Wednesday, 10-hour days
• Some holiday coverage may be necessary
• Occasional overtime may be required to meet project deadlines
• Some travel may be required for conferences, training, or client meetings

By applying, I understand that any offer of employment is contingent upon the successful completion of a background check, in accordance with applicable laws.